Chlorhexidine gluconate vs povidone-iodine vaginal antisepsis for urogynecologic surgery: a randomized controlled noninferiority trial

Although povidone-iodine (iodine) is the only Food and Drug Administration–approved vaginal antiseptic solution, there is a lack of comparative data evaluating alternatives. Chlorhexidine gluconate is readily accessible, recommended by multiple societies as an alternative for patients with iodine allergy, and preliminary data indicate that it may provide superior antisepsis. This study aimed to compare the effectiveness of chlorhexidine and iodine as presurgical vaginal antiseptic solutions in preventing the most common surgery-associated infection after gynecologic surgery, urinary tract infections. We conducted a randomized controlled noninferiority trial among women undergoing urogynecologic surgery. The primary outcome measure was symptomatic urinary tract infection within 2 weeks after surgery. The secondary outcomes included culture-proven urinary tract infection at 2 and 6 weeks after surgery, symptomatic urinary tract infections at 6 weeks after surgery, any surgical site infection at 2 weeks after surgery, and patient-reported vaginal irritation after surgery. We required 58 participants per arm to demonstrate noninferiority of chlorhexidine vs iodine (margin of relative risk of